Cholangiocarcinoma
Conditions
Interventions
Experimental group:Adbelimumab+apatinib+capecitabine+oxaliplatin
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily participate in this study and sign informed consent; 2) Both male and female, aged 18-75 years old; 3) Subjects with histologically confirmed cholangiocarcinoma (histology and/or cytology); 4) Surgically resectable as assessed by the surgeon according to the 8th edition of the AJCC as follows: intrahepatic cholangiocarcinoma, T1b-4NanyM0, IB-IIIB stage; Hilar cholangiocarcinoma, T2-3N0-1M0, stage IIA-IIIA; Distal cholangiocarcinoma,T2-3N0-2M0, stage IIA-IIIA; 5) No previous systemic treatment; 6)ECOG performance status score (PS score) 0 or 1; 7) Vital organ function indicators met the following requirements: neutrophil =1.5×109/L; Platelet count =75×109/L; Hemoglobin =90 g/L; Serum albumin =30 g/L; Bilirubin = 1.5 times the upper limit of normal value; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 times the upper limit of normal (initial drainage was allowed); Serum creatinine = 1.5 times the upper limit of normal, creatinine clearance =60 ml/min; Thyroid stimulating hormone (TSH) = 1 times the upper limit of normal, T3, T4 in the normal range; 8)Women of childbearing age must have a negative pregnancy test for (ß-HCG) before starting treatment, and women of childbearing age and men (who have sex with women of childbearing age) must agree to contraception during treatment and within 6 months of the last treatment.
Exclusion criteria
Exclusion criteria: 1) History of other primary malignancy, except a. Malignancy treated with curative intent and free of known active disease =5 years before first dose with a low potential risk of recurrence b. Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ with no evidence of disease; 2) Patients with current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia that may interfere with the identification and management of immune-related pulmonary toxicity (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or active pneumonia or severely impaired lung function on chest CT during the screening period; Active tuberculosis; 3) Have active autoimmune disease or a history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (eligible if controlled only with hormone replacement therapy); Patients with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood without any intervention in adulthood were eligible. Patients with asthma who required medical intervention with a bronchodilator were excluded. 4) Use of immunosuppressive agents or systemic steroids for immunosuppression within 2 weeks before the first study treatment (prednisone or other equivalent steroids at a dose of >10 mg/ day); 5) Patients with active infection, unexplained fever =38.5? within 1 week before the first study treatment, or baseline white blood cell count >15×109/L; Therapeutic oral or intravenous antibiotics administered within 2 weeks before the first study treatment (except prophylactic intravenous antibiotics administered for no more than 48 hours); 6) Congenital or acquired immune deficiency (such as HIV infection); 7) Have received a live attenuated vaccine within 4 weeks before the first study dose or are expected to require such vaccine within 60 days after the last study dose; 8) Patients with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months before the first study treatment, such as gastrointestinal bleeding, severe esophagogastric varices, hemorrhagic gastric ulcer, or angiitis, can be re-examined if the stool occult blood is positive at baseline. If the stool occult blood is still positive after re-examination, gastroscopy is required; 9) Known inherited or acquired bleeding (e.g. coagulopathy) or thrombophilia, as in hemophilia patients, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant or thrombolytic therapy (prophylactic use, such as low-dose aspirin, was allowed); 10) Arterial thromboembolism events occurred within 6 months before the first study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc.; 11) Have uncontrolled cardiac symptoms or diseases, such as: (1) New York Heart Association (NYHA) class II or above cardiac dysfunction or color Doppler echocardiograp
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Major pathological response (MPR) rate;Pathological complete response (pCR) rate;Recurrence-free survival ;R0 resection rate;Overall survival;Surgical safety;Safety of medical treatment; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactBeicheng Sun
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed